Diabetes Mellitus, Type 2ELSCNCT01236794
Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts
A study testing Lifestyle Education Sessions and Youth Exercise Sessions in people with Diabetes Mellitus, Type 2, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of a lifestyle intervention program on type 2 diabetes risk factors and quality of life in overweight Latino youth. Read more about this study
- Who is it for?
- Ages 14 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lifestyle Education Sessions and Youth Exercise Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Hispanic Ethnicity (Child and Parent)
- Age 14-16 (Child) and Parent age < 85
- BMI Percentile above the 85th (child)
- Ability to read and speak English (child)
Who cannot join
- Taking medication(s) or diagnosed with a condition that could influence exercise ability or carbohydrate metabolism (e.g., polycystic ovarian syndrome, exercise induced asthma, orthopedic limitations) (Child and (Parent OGTT only))
- Involved in any formal weight-loss program in the past 6 months (Child)
- Diagnosed diabetes (type 1 or type 2 Child)
- Weight is less than 110 Ibs (Child and Parent)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effects of a lifestyle intervention program on type 2 diabetes risk factors and quality of life in overweight Latino youth.
Read the detailed description
With the increasing prevalence of obesity, the incidence of obesity-related co-morbidities including depression and type 2 diabetes have emerged as critical public health conditions. Furthermore, Latinos experience a disproportionately greater burden of these obesity-related disorders. Therefore, we have developed a 12-week community-based lifestyle intervention that includes weekly education sessions for children and their parents and 3 exercise sessions per week for youth. The program will be delivered at a local YMCA in the greater Phoenix Metropolitan area.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lifestyle Education Sessions and Youth Exercise Sessions
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Education Sessions and Youth Exercise SessionsBehavioural
Also called ELSC, Every Little Step Counts
The intervention will include a ~1-2 hour weekly education session to address the following constructs: health awareness, healthy eating, physical activity, roles and responsibilities, self-esteem, self-efficacy, diabetes knowledge, communication, and peer / family relationships. In addition to the education classes youth will participate in 3 exercise sessions per week (~1-1.5 hrs) that will consist of individual and group physical activities to include both aerobic and resistance exercises. The exercise intensity will progressively increase over the 12-week intervention. Both the education and activity sessions will be delivered at the Lincoln Family YMCA.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle and Exercise Intervention | Experimental | Not described Receives: Behavioral: Lifestyle Education Sessions and Youth Exercise Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Insulin sensitivity will be determined using a insulin and glucose values collected during a 2-hour oral glucose tolerance test.
Measured: About 12 Weeks
Secondary outcomes (1)
QOL
Weight-specific quality of Life will be determined by self report using a multicultural quality of life instrument for adolescents
Measured: About 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), St. Vincent de Paul Medical and Dental Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236794
- Sponsor's protocol ID
- P20MD002316ELSC
- Other IDs
- P20MD002316
- Acronym
- ELSC
- Status last verified
- Jun 2018
- First submitted
- 14 Sep 2010
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Shaibi GQ, Konopken Y, Hoppin E, Keller CS, Ortega R, Castro FG. Effects of a culturally grounded community-based diabetes prevention program for obese Latino adolescents. Diabetes Educ. 2012 Jul-Aug;38(4):504-12. doi: 10.1177/0145721712446635. Epub 2012 May 14.
PubMed 22585870Shaibi GQ, Greenwood-Ericksen MB, Chapman CR, Konopken Y, Ertl J. Development, implementation, and effects of community-based diabetes prevention program for obese latino youth. J Prim Care Community Health. 2010 Oct 1;1(3):206-12. doi: 10.1177/2150131910377909.
PubMed 21461141Ryder JR, Vega-Lopez S, Ortega R, Konopken Y, Shaibi GQ. Lifestyle intervention improves lipoprotein particle size and distribution without weight loss in obese Latino adolescents. Pediatr Obes. 2013 Oct;8(5):e59-63. doi: 10.1111/j.2047-6310.2013.00162.x. Epub 2013 Apr 10.
PubMed 23576420
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts
- ClinicalTrials.gov ID
- NCT01236794
- Acronym / sponsor ID
- ELSC / P20MD002316ELSC
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), St. Vincent de Paul Medical and Dental Clinic
- Study start
- May 2010 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of a lifestyle intervention program on type 2 diabetes risk factors and quality of life in overweight Latino youth.
Detailed description
With the increasing prevalence of obesity, the incidence of obesity-related co-morbidities including depression and type 2 diabetes have emerged as critical public health conditions. Furthermore, Latinos experience a disproportionately greater burden of these obesity-related disorders. Therefore, we have developed a 12-week community-based lifestyle intervention that includes weekly education sessions for children and their parents and 3 exercise sessions per week for youth. The program will be delivered at a local YMCA in the greater Phoenix Metropolitan area.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle and Exercise Intervention | Experimental | Behavioral: Lifestyle Education Sessions and Youth Exercise Sessions |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Hispanic Ethnicity (Child and Parent)
- Age 14-16 (Child) and Parent age < 85
- BMI Percentile above the 85th (child)
- Ability to read and speak English (child)
Key exclusion criteria (4 listed)
- Taking medication(s) or diagnosed with a condition that could influence exercise ability or carbohydrate metabolism (e.g., polycystic ovarian syndrome, exercise induced asthma, orthopedic limitations) (Child and (Parent OGTT only))
- Involved in any formal weight-loss program in the past 6 months (Child)
- Diagnosed diabetes (type 1 or type 2 Child)
- Weight is less than 110 Ibs (Child and Parent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Education Sessions and Youth Exercise SessionsAlso: ELSC, Every Little Step CountsThe intervention will include a ~1-2 hour weekly education session to address the following constructs: health awareness, healthy eating, physical activity, roles and responsibilities, self-esteem, self-efficacy, diabetes knowledge, communication, and peer / family relationships. In addition to the education classes youth will participate in 3 exercise sessions per week (~1-1.5 hrs) that will consist of individual and group physical activities to include both aerobic and resistance exercises. The exercise intensity will progressively increase over the 12-week intervention. Both the education and activity sessions will be delivered at the Lincoln Family YMCA. | Behavioural | Lifestyle and Exercise Intervention |
Primary outcome
Insulin Sensitivity
Time frame: About 12 Weeks
Insulin sensitivity will be determined using a insulin and glucose values collected during a 2-hour oral glucose tolerance test.
1 secondary outcome
QOL
Time frame: About 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Results publication: PubMed 22585870Shaibi GQ, Konopken Y, Hoppin E, Keller CS, Ortega R, Castro FG. Effects of a culturally grounded community-based diabetes prevention program for obese Latino adolescents. Diabetes Educ. 2012 Jul-Aug;38(4):504-12. doi: 10.1177/0145721712446635. Epub 2012 May 14.
- Results publication: PubMed 21461141Shaibi GQ, Greenwood-Ericksen MB, Chapman CR, Konopken Y, Ertl J. Development, implementation, and effects of community-based diabetes prevention program for obese latino youth. J Prim Care Community Health. 2010 Oct 1;1(3):206-12. doi: 10.1177/2150131910377909.
- Results publication: PubMed 23576420Ryder JR, Vega-Lopez S, Ortega R, Konopken Y, Shaibi GQ. Lifestyle intervention improves lipoprotein particle size and distribution without weight loss in obese Latino adolescents. Pediatr Obes. 2013 Oct;8(5):e59-63. doi: 10.1111/j.2047-6310.2013.00162.x. Epub 2013 Apr 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Education Sessions and Youth Exercise Sessions in people with Diabetes Mellitus, Type 2, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: About 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236794, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.